Last reviewed 2026-04-20 · How we verify

Dihexyverin (DIHEXYVERINE)

Phase 2 active Small molecule

Dihexyverin (generic name: DIHEXYVERINE) is a dihexyverine drug. It is currently in Phase 2 development.

Dihexyverine is thought to work by inhibiting smooth muscle contraction, although the exact mechanism is unclear.

Dihexyverine is a small molecule drug in the dihexyverine class, but specific details about its target, pharmacokinetics, and commercial status are unknown. Its mechanism of action and approved indications are also unclear. As a result, there is limited information available about this compound. Further research is needed to understand its potential therapeutic applications and safety profile. Its current status and development stage are also unknown.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	DIHEXYVERINE
Drug class	dihexyverine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your muscles are like rubber bands - when they contract, they get shorter and tighter. Dihexyverine is believed to help relax these muscles, making them less tight and less likely to cause problems. This can be helpful in treating conditions where muscle spasms or contractions are a concern.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Dihexyverin CI brief — competitive landscape report
Dihexyverin updates RSS · CI watch RSS

Frequently asked questions about Dihexyverin

What is Dihexyverin?

Dihexyverin (DIHEXYVERINE) is a dihexyverine drug.

How does Dihexyverin work?

Dihexyverine is thought to work by inhibiting smooth muscle contraction, although the exact mechanism is unclear.

What is the generic name of Dihexyverin?

DIHEXYVERINE is the generic (nonproprietary) name of Dihexyverin.

What drug class is Dihexyverin in?

Dihexyverin belongs to the dihexyverine class. See all dihexyverine drugs at /class/dihexyverine.

What development phase is Dihexyverin in?

Dihexyverin is in Phase 2.

Drug class: All dihexyverine drugs
Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing